Maico MA 28 Operation Manual page 9

WARNING
WARNING
WARNING
WARNING
8506915 Rev. 5
To transfer data to a PC, establishing a PC-connection via USB
is required. See section 4.2.4 on how to safely establish a
connection with a power supplied PC or laptop (medical
device/non-medical device) or to a battery-driven laptop.
This equipment is intended to be connected to other equipment
thus forming a Medical Electrical System. External equipment
intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for
medical electrical equipment. In addition, all such combinations
– Medical Electrical Systems – shall comply with the safety
requirements stated the general standard IEC 60601-1, edition
3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1shall be kept outside the
patient environment i.e. at least 1.5 m from the patient support
or shall be supplied via a separation transformer to reduce the
leakage currents. Any person who connects external equipment
to signal input, signal output or other connectors has formed a
Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact
qualified medical technician or your local representative.
If the device is connected to a PC (IT equipment forming a
system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations
in IEC 60601-series.
The consequence of not following this warning could be a
too high leakage current to the patient.
Do not touch the contacts of the device and the patient at the
same time. When connected to computer equipment do not
simultaneously touch the computer equipment and the patient
at the same time. The consequence could be a too high leakage
current to the patient.
The device is not intended for operation in areas with an
explosion hazard. Do NOT use the MA 28 in a highly
oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc. If the device is not used switch it
off and disconnect it from the power supply.
Never short-circuit the terminals.
To avoid the risk of electric shock, this equipment must only
be connected to the medical power supply originally
delivered by MAICO. Using another power supply can also
lead to electrical damage on the device.
Prevent cable breakage: cables must not be bent or buckled.
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Operation Manual MA 28
05/05/2021